Amgen

Sr Engineer - Process Development Drug Product Packaging

Employer
Amgen
Location
Juncos, PR, US
Posted
Feb 11, 2019
Ref
R-70267
Required Education
Associate Degree
Position Type
Full time
SUMMARY

Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Supports the execution of manufacturing/quality systems such as non-conformance, process validation, equipment commissioning and qualification, process monitoring, and new product introductions.

Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

The Sr. Engineer will be supporting a non-standard shift organization that may include first, second, third and/or weekend shifts structure. This role is crucial for Amgen's success and it will be a key contributor in the Process Development - Drug Product Packaging organization.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
  • Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
  • Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
  • Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
  • Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
  • Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
  • Application of mature engineering knowledge in planning and conducting projects.
  • Prompt and regular attendance to workplace
  • Provide solutions to a large variety of technical problems of moderate to large complexity and scope
  • Work with research, manufacturing, process development, utilities, facilities, quality assurance in developing requirements and recommendations for large and/or highly complex system/facility modifications.
  • Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
  • Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
  • Interacts effectively with variety of communication and working styles.
  • Handle multiple projects at one time.
  • Application of scientific and engineering theory and calculations.


BASIC QUALIFICATIONS - EDUCATION & EXPERIENCE

Doctorate degree in Engineering

OR

Master's degree in Engineering & 3 years of manufacturing, process development and/ or technical services experience within a GMP regulated industry

OR

Bachelor's degree in Engineering & 5 years of manufacturing, process development and/ or technical services experience within a GMP regulated industry

PREFERRED QUALIFICATIONS
  • Educational background in Computer, Chemical, Industrial, Mechanical and/or Electrical Engineering.
  • Working knowledge or experience in a Drug Product- Inspection & Packaging organization.
  • Detailed technical understanding of bio-processing unit operations for upstream and cell harvest processes.
  • Understanding of equipment commissioning and qualification, validation and documentation processes in a highly regulated environment.
  • Ability to operate specialized laboratory equipment and computers as appropriate.
  • Ability to interpret and apply GLPs and GMPs.
  • Ability to apply engineering science to production.
  • Interacts effectively with variety of communication and working styles.
  • Ability to handle multiple projects at one time
  • Skills in the development of hypotheses and approach.
  • Demonstrated skills in the following areas:
    • Problem solving and applied engineering.
    • Basic technical report writing
    • Fully bilingual (Spanish and English)
    • Basic technical presentations
    • Personal Organization
    • Equipment Commissioning / Qualification / Validation Protocol Writing
    • Dealing with and managing change
    • Technical (Equipment Specific)
    • Analytical Problem Solving
    • Computer Literacy
    • Negotiation, persuasion and facilitation
    • Project cost development
    • Conflict Resolution
    • Leadership and team building
    • Schedule and resources loading development
    • Flexibility to work off-hours


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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